Kornimate/medical-research-clean huggingface dataset:
short-term cognitive training in late-life depression

Conditions: Depression

Summary: the purpose of this study is to examine the effects of the alternative uses training (aut) and word association training (wat) on cognitive functions and mood symptoms in late-life depression (lld). the hypotheses are: 1. post-training cognitive performance will be superior to pre-training cognitive performance 2. post-training depressive symptomatology will be less severe as compared with pre-training clinical severity and 3. aut group will show better post-training cognitive performance and improved mood symptoms when compared with the wat group.


Eligibility criteria:
inclusion criteria: * male or female * age \>=55 * proficiency in english * current depressive episode and meet criteria for dsm-iv major depressive disorder * hamilton depression rating scale score \>=15 * able to give informed consent * stable medication dosages during the training period exclusion criteria: * other dsm-iv axis i psychiatric disorders, except for anxiety disorders due to high comorbidity with mood disorders * mini-mental state examination score of \<26 * diagnosis of dementia * neurological and medical conditions known to affect cognition (e.g., stroke, head injury, previous chemotherapy for cancer) * unstable medical illnesses requiring active treatment * vision or hearing impairment affecting ability to participate in training

Keywords: depression intervention studies
photodynamic therapy with luz11 in advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: this study will investigate the tolerability, recommended dose and pharmacokinetics of luz11 following photodynamic therapy (pdt) of patients with advanced head and neck cancer.

luz11 is a new photosensitizer for use in photodynamic therapy (pdt) of solid tumors, such as head and neck cancer. pdt with luz11 involves the intravenous administration of luz11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. the light causes the drug to react with oxygen, which forms reactive oxygen species (ros) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients. the primary objective of this study is to assess the tolerability of luz11 following single ascending doses of luz11. the secondary objectives of this study are to explore the luz11 dose that has anti-tumor effect following photoactivation and to determine luz11 pharmacokinetics.

Eligibility criteria:
inclusion criteria: * written informed consent * men or non-pregnant, non-breast feeding women * karnofsky performance status of 60% or greater * histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck * clearly visible tumor on the oral cavity or cutaneous surface exclusion criteria: * known hypersensitivity to any of the formulation ingredients * known hypersensitivity to porphyrins * porphyria or other diseases exacerbated by light * tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site * planned skin phototherapy session(s) within the study timeframe * planned surgical procedure within the study timeframe * coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe * existing therapy with a photosensitizing agent * unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening * myocardial infarction within 6 months prior to screening * contraindication to mri with gadolinium * unacceptable laboratory abnormalities * clinically relevant 12-lead ecg abnormalities

Keywords: luz11 head and neck cancer photodynamic therapy redaporfin
barbed suture in single-port laparoscopic myomectomy

Conditions: Uterine Myoma

Summary: the aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.

the investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. all women will get the same preoperative and postoperative care. women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using v-loc™ suture material (study group). the other group will receive conventional multi-port laparoscopic myomectomy using v-loc™ suture material (control group). the investigators will collect information on suturing time and complications related to surgery.

Eligibility criteria:
inclusion criteria: * age between 18 and 55 years * image-confirmed uterine myoma * number of myoma ≤2 and largest size ≤10cm * women who were scheduled to have laparoscopic myomectomy * appropriate medical status for laparoscopic surgery (american society of anesthesiologists physical status classification 1 or 2) exclusion criteria: * women with pedunculated subserosal myoma or submucosal myoma * women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis * women with any suggestion of malignant uterine or adnexal diseases * women with diabetics, malignancy, or malnutrition, which can affect wound healing * women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance * women who refuse to participate or give consent to the procedures
alternate day fasting and exercise in overweight or obese adults

Conditions: Overweight; Obesity; Diet Modification; Exercise

Summary: alternate day fasting is known to be helpful to control weight and have a positive effect on insulin resistance and cardiovascular risk factors. however, there have been no studies on weight reduction program combining alternate day fasting with exercise which preserves lean mass in korea. the purpose of this randomized clinical trial is to examine the effects of alternate day fasting and exercise on weight reduction, visceral fat, and metabolic parameters in overweight or obese adults.


Eligibility criteria:
inclusion criteria: * age 20-65 years * body mass index (bmi) more than 23.0 kg/m² (overweight or obese for asian populations, according to the world health organization) exclusion criteria: * participants with weight gain more than 5kg in the last 3 months * participants with history of bariatric surgery * participants with secondary obesity, such as hypothyroidism * participants with uncontrolled hypertension or type 1 diabetes * participants who are taking anti-diabetic medications due to type 2 diabetes * participants with hepatic disease (ast or alt ≥200 mg/dl) * participants with renal disease (serum creatinine ≥2.0 mg/dl) * participants with pancreatitis or related disorders * participants with acute infectious diseases (i.e., pneumonia, acute enteritis, or urinary infection) * participants with chronic inflammatory diseases (i.e., rheumatoid arthritis, or lupus) * participants with overeating behavior * participants with history of cardiovascular diseases * participants with history of cancer * participants who are taking anti-obesity, anti-diabetic, diuretic, central-nervous system, antidepressant, antipsychotic, or steroid medications * pregnant or lactating women * participants who intake more than 30 g of alcohol daily * night-time or shift-work workers * participants with chronic malabsorption syndrome or cholestasis * participants with other medical conditions that would preclude subjects from participating in exercise and physical test
study to evaluate the efficacy and safety of topical mob015b in the treatment of mild to moderate distal subungual onychomycosis (dso)

Conditions: Distal Subungual Onychomycosis

Summary: the primary objective of this study is to evaluate the efficacy of topical mob015b in patients with mild to moderate distal subungual onychomycosis (dso). the secondary objective is to evaluate the safety of topical mob015b in patients with mild to moderate dso.


Eligibility criteria:
inclusion criteria: 1. males or females 18 - 75 years of age 2. distal subungual onychomycosis (dso) of at least one of the great toenail(s) affecting 20% to 60% of the target nail 3. positive culture for dermatophytes 4. signed written informed consent exclusion criteria: 1. proximal subungual onychomycosis 2. distal subungual onychomycosis of both great toenails where involvement has extended into the proximal portion of the target nail (unaffected proximal nail is less than 3 mm) 3. target toenail thickness more than 3 mm 4. "spike" of onychomycosis extending to eponychium of the target toenail 5. presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail 6. other conditions than dso known to cause abnormal nail appearance 7. presence of toenail infection other than dermatophytes 8. previous target toenail surgery with any residual disfigurement 9. topical treatment of the nails with other antifungal medication or medical device within 6 weeks before screening/visit 1 10. systemic use of antifungal treatment within 6 months before screening/ visit 1 11. severe moccasin tinea pedis 12. signs of severe peripheral circulatory insufficiency 13. uncontrolled diabetes mellitus 14. known immunodeficiency 15. participation in another clinical trial with an investigational drug or device during the previous 3 months before baseline/ visit 2 16. known allergy to any of the tested treatment products 17. a positive pregnancy test indicating pregnancy in a woman of childbearing potential at baseline/ visit 2 18. females who are pregnant or breastfeeding 19. pre-menopausal (last menstruation ≤ 1 year prior to screening) sexually active women who are of childbearing potential and are not practicing an acceptable method of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial 20. patients previously randomized in this study 21. history of, or current drug or alcohol abuse 22. psychiatric condition that might limit the participation in the study and/or that lead to the assumption that the patient's ability to completely understand the consequences of consent is missing 23. close affiliation with the investigator (e.g. a close relative) or persons working at a study site, or patient who is an employee of the sponsor's company 24. patients who are institutionalized because of legal or regulatory order 25. any diseases or circumstances in which the patient should not participate in the study in the opinion of the investigator
fresh food farmacy: a randomized controlled trial

Conditions: Type 2 Diabetes

Summary: this trial investigates the value created by the highly innovative fresh food farmacy (fff) program at geisinger health. the program provides food-insecure diabetics with healthy food for their entire household: at least two meals per day, five days a week. the program also provides education on how to prepare the food, and education on healthy living including diabetes self management. the research measures the effects of the fff program on patient health and wellbeing.

this is a pragmatic, prospective, randomized controlled trial of geisinger's fresh food farmacy (fff) program as the program expands to new sites. qualifying subjects will be randomized 1:1 to receive either early participation in the fff program (treatment group) or later participation (control group). approximately 500 geisinger subjects will participate in this study with about half assigned to the treatment group and about half to the control group. the treatment group will begin the program soon after trial recruitment: the "begin now" group. the control group will begin the program after 6 months: the "begin later" group. approximately 2000 household members will be included in the data-only portion of the research. outcomes will include clinical measures, such as hba1c, survey responses including self-assessed health measures, and utilization / healthy-behavior measures from ehr and paid claims data. these will be measured for subjects and their household members.

Eligibility criteria:
inclusion criteria: * type ii diabetes and an hba1c ≥ 8.0 as determined by the most recent measurement in the geisinger emr within the prior 12 months * food insecure based on a two-question survey instrument * age \> 17 \& age \<86 * living within geographic reach of the program (lewistown, pa and scranton, pa) exclusion criteria: * already enrolled in fff in shamokin * not english speaking (working on changing this as the program evolves) * on hospice or palliative care * acute or chronic psychosis * resides in a facility which provides meals * active medical disorder that would preclude participation in the classes, weekly clinic visits, or result in a limited diet, including: * cancer; active treatment * steroid dependent asthma/ copd/ emphysema * steroid dependent colitis * chronic kidney disease with gfr\< 30 mg/mmol * celiac disease * cirrhosis * steroid dependent arthritis

Keywords: diabetes
effect of curcumin as nutraceutical in patients of depression

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to find the effect of commonly used nutraceutical curcumin ( extract of curcuma longa, commonly called 'haldi' in hindi) in patients of depression.


Eligibility criteria:
inclusion criteria: * depression as diagnosed under dsm-iv axis i disorders. * score greater than 7 but less then 35 on the 17-item hamilton depression (ham-d) scale at screening. * the patient has relative(s) to care for him/her * informed consent obtained from the patient or relative exclusion criteria: * scores greater than 2 on the "suicide" item of ham-d, or history of suicide attempt(s) in the past 12 months. * current suicidal or homicidal risk, as determined by the investigator. * clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal. * history of seizure disorder (other than febrile). * patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days * any of the following dsm-iv diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent) * patient with history of untreated or unstable thyroid disorder * failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or maoi equivalent, or greater than or equal to 100 mg of sertraline, or its ssri equivalent. * have had other investigational drugs within 30 days or other psychotropic medication within 21 days. * known allergy or hypersensitivity to the study medications. * receiving psychotherapies which are specifically designed to treat depression, eg, interpersonal psychotherapy during the study period. * mental retardation or cognitive impairment, or any disorder that might interfere with their ability to give consent or follow study procedures and requirements. * in case of female patients, abstinence or effective method of contraception throughout the study

Keywords: depression
effect of 12-week fw programme on sex hormone levels and risk factors for ms in postmenopausal women

Conditions: Postmenopause Women

Summary: postmenopausal women were separated into two groups: one participating in a 12-week fitness walking programe as the fitness walking group, and the other maintaining their regular lifestyle as the control group. the study evaluated alterations in health markers and examined the correlation between metabolic syndrome risk factors and sex hormone levels before and after the intervention.

according to the inclusion and exclusion criteria, our study invlved postmenopausal women aged from 50 to 69 years old. after the selection process, baseline assessments were conducted, including evaluations of metabolic syndrome risk factors, body morphology measurements, sex hormone levels, and cardiopulmonary exercise testing. participants were then randomly assigned to either the fitness walking group or the control group using a random number table. participants in the fitness walking group completed a 12-week fitness walking program, while those in the control group maintained their usual lifestyle without any intervention. during the post-intervention assessment, all baseline measurements were repeated to evaluate changes in the previously measured indicators.

Eligibility criteria:
inclusion criteria: * (1) participants were entirely voluntary and capable of completing the full 12-week intervention process. * (2) participants were postmenopausal women aged between 50 and 69 years. * (3) participants had been postmenopausal for over 12 months and had not received exogenous estrogen supplementation post-menopause. exclusion criteria: * (1) participants had a history of acute or chronic musculoskeletal disorders, cardiovascular diseases, diabetes, or other conditions that might impact their ability to engage in the intervention. * (2) participants had recent hormone treatment, anti-inflammatory medication use, or other medications affecting blood indices. * (3) participants experienced unstable body weight (fluctuations exceeding 2.5 kg) in the past three months. * (4) participants were concurrently enrolled in other intervention studies or maintained regular exercise routines. * (5) participants had smoking or alcohol consumption habits.

Keywords: exercise postmenopause women's health metabolism sex hormone
the effectiveness of therapeutic virtual reality versus pharmacological sedation on pain and anxiety during interventional cardiology procedures

Conditions: Virtual Reality; Drug Sedation; Coronarography; Angiography

Summary: immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control. the objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.


Eligibility criteria:
inclusion criteria: * adult patient * who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs) * affiliation to a social security scheme or beneficiary of such a scheme. * patient having signed the free and informed consent exclusion criteria: * dementia * language barrier * claustrophobia * nausea * history of intolerance to virtual reality * patient with epilepsy * refusal to participate in the study * protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * pregnant, breastfeeding or parturient woman * unstable patient (state of shock, respiratory or neurological distress)
a study to test different doses of bi 1831169 alone and in combination with an anti-pd-1 antibody in people with different types of advanced cancer (solid tumors)

Conditions: Solid Tumors

Summary: this study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. this is a study for people with a life expectancy of at least 3 months after starting study treatment. the purpose of this study is to find the highest dose of a medicine called bi 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-pd-1 antibody). another purpose is to check whether the study treatment can fight cancer. in this study, bi 1831169 is given to people for the first time. this study has 2 parts. in part 1, participants get bi 1831169 alone for up to 3 months. in part 2, participants get bi 1831169 in combination with a checkpoint inhibitor. participants who take the combination treatment get bi 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. bi 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). checkpoint inhibitors are given as an infusion into a vein. participants get the medicines about every 3 weeks. this is called a treatment cycle. participants visit the site study site regularly. the number of study visits vary based on the study phase and treatment response. some visits include an overnight stay. the doctors regularly check the participants' health and monitor the tumors. the doctors also take note of any health problems that could have been caused by the study treatment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors * at least one or two accessible lesions, one with a minimum lesion diameter for injection of bi 1831169 (where applicable), and one which is amenable to biopsy (where applicable). lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of bi 1831169 * has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. patient must have exhausted available treatment options known to prolong survival for their disease. this criterion does not apply to the specific indications in part 2. further inclusion criteria apply. exclusion criteria: * previous treatment with vesicular stomatitis virus (vsv)-based agents * concomitant medication or condition considered a high risk for complications from injection or biopsy as per the investigator's judgement * presence of brain metastases * presence of human immunodeficiency virus (hiv) meeting certain criteria, active autoimmune disease or chronic active infection (hepatitis c or b virus (hcv/hbv)) * chronic steroid use, regardless of daily dose further exclusion criteria apply.